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Kindly suggest is it necessary to conduct BE study of Artemether-
Lumefantrine formulation under fasting condition
As mentioned in product monograph:
Administration and food
Although patients with acute malaria are frequently intolerant of
should be taken with fluids (particularly drinks containing fats,
such as milk)
and if possible, with a normal diet, as soon as the patient can
Ingestion with fat-containing food and drinks markedly improves
Although any risk of recrudescence is very small, patients who remain
food during treatment should be closely monitored.
This statement mean formulation to be taken under fed condition.
But as per US Guidelines,
In addition to a BE study under fasting conditions, we recommend a BE
study under fed conditions for all orally administered immediate-
release drug products, with the following exceptions:
.. When both test product and RLD are rapidly dissolving, have similar
dissolution profiles, and contain a drug substance with high
solubility and high permeability (BCS Class I), or
.. When the DOSAGE AND ADMINISTRATION section of the RLD label states
that the product should be taken only on an empty stomach, or
.. When the RLD label does not make any statements about the effect of
food on absorption or administration.
Awaiting for your expert comments.
Thanks & regards,
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